Hypertonic Lactate After Cardiac Arrest
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital
About this trial
The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old
Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
Comatose (GCS < 9)
Time to ROSC > 15'
Disqualifiers
Protected categories (Pregnant women)
Anticipated withdrawal of support within 24 hours
Traumatic cause of cardiac arrest
Body weight at admission > 120Kg
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Lactate Solution
Drugcontinuous intravenous infusion of molar sodium lactate
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: standard of careNo intervention 0 interventions
Group B: treatement groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
serum NSE
NSE serum levels
Time frame
48 hours after randomizationSecondary outcomes
1
ICU length of stay
number of days in the intensive care unit
Time frame
trough study completion, on average 30 days2
Mortality
mortality
Time frame
trough study completion before hospital discharge, on average 90 days3
Neurological outcome
Neurological outcome measured by Cerebral Performance Category score at 90 days (1-5, 1 meaning better Neurological outcome)
Time frame
trough study completion, 90 days after randomization4
Hospital length of stay
Hospital length of stay
Time frame
trough study completion, on average 60 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov